# FDA recall D-0246-2025

> **Padagis US LLC** · Class II · drug recall initiated 2025-02-06.

## Product

Estradiol Gel, 0.1%, 0.25 mg/g, 30 packets per carton, Rx Only, For Topical Use Only, Manufactured by Padagis, Yeruham, Israel, NDC: 45802-0134-30

## Reason for recall

Defective Container: Some packets may not be fully sealed, potentially allowing for loss of Ethanol from the product.

## Distribution

Nationwide in the USA

## Key facts

- **Recall number:** D-0246-2025
- **Recalling firm:** Padagis US LLC
- **Classification:** Class II
- **Product type:** drug
- **Status:** Completed
- **Initiation date:** 2025-02-06
- **Report date:** 2025-03-05

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Minneapolis, MN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0246-2025

## Citation

> AI Analytics. FDA recall D-0246-2025. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/D-0246-2025. Source: US FDA. Licensed CC0.

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